Preterm delivery affects more than 10% of all pregnant mothers. It is also one of the leading causes of illness and death associated with newborns. Compared with babies born at term, infants born prematurely experience a 40-fold increase in neonatal death, and may be at significantly increased risk for major medical complications such as cerebral palsy, chronic respiratory illness, blindness and deafness. Furthermore, long-term neurologic and developmental problems have been identified in as many as 70% of children with birth weight less than 1.5 lbs. It has been estimated that these complications are associated with billions of dollars of direct costs and unrealized potential each year just in the United States.
Despite the significance of the problem, there has been uncertainty as to what occurs in the body that leads to preterm labor and delivery. Although the ability to effectively treat these problems remain limited due to the uncertainty that exists regarding the causes of preterm birth (PTB), medical measures may be taken by medical professionals if given adequate advance warning. If one could predict which pregnant mothers were likely to experience preterm birth, medications may be administered that might delay or even prevent premature delivery. Additionally, there hormone derivatives are known that can enhance fetal lung maturity and thus reduce one of the major complications associated with preterm birth if administered to the fetus via the mother if the risk of preterm birth is detected sooner than later. However, at present there appears to be no way of knowing which pregnant mothers are at risk to develop this complication of pregnancy. Therefore, an important unmet need is to formulate a testing procedure for the early detection of mothers at risk for preterm birth.